MAUDE Adverse Event Report: BAUSCH + LOMB ENVISTA ENVY HYDROPHOBIC ACRYLIC INTRAOCULAR LENS; LENS, MULTIFOCAL INTRAOCULAR

Model Number	EN
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Visual Impairment (2138); Toxic Anterior Segment Syndrome (TASS) (4469); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/11/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device remains implanted.A review of the lot device history record (dhr) did not identify any anomalies or nonconformities that could be related to this event.Based on the available information, the root cause of this event could not be determined.Bausch + lomb will continue to monitor for similar occurrences.
Event or Problem Description
It was reported that 1-day after implantation of an intraocular lens (iol) into the left eye (os), the patient presented with increased inflammation with slit lamp findings of 3+ cell and significant fibrin.The patients best corrected visual acuity (bcva) decreased to 20/150.Based on the findings the surgeon concluded the cause as toxic anterior segment syndrome (tass).Approximately 1 week after onset of problem, the fibrin was reported to be resolved, visual acuity increased to 20/60, and the patient was directed to continue using durezol.At 3 weeks post-op, there was allegedly still some cell present.In the surgeon's opinion, the most likely cause of the event is possible tass from the iol.Medications prescribed for use at home post-operatively: pred 1%/moxi 0.5%/brom 0.075% tid x 1 week.Pred 1%/moxi 0.5%/brom 0.075% qd x 3 weeks.Durezol every hour.Medrol dose pack daily taper.
Additional Manufacturer Narrative
Additional info: b5, g3, h2, h11.
Event or Problem Description
Additional information was received indicating the tass event may have been caused by a cannula and unrelated to the lens.Additional information was requested but not received.

• Brand Name: ENVISTA ENVY HYDROPHOBIC ACRYLIC INTRAOCULAR LENS
• Common Device Name: LENS, MULTIFOCAL INTRAOCULAR
• Manufacturer (Section D): BAUSCH + LOMB; 1400 north goodman street; rochester NY 14609
• Manufacturer (Section G): BAUSCH + LOMB; 21 north park place blvd.; clearwater FL 33759
• Manufacturer Contact: shayan habibi ; 21 north park place blvd.; clearwater, FL 33759 ; 7277246600
• MDR Report Key: 22727296
• Report Number: 0001313525-2025-00156
• Device Sequence Number: 9051001
• Product Code: MFK
• UDI-Device Identifier: 10757770637536
• UDI-Public: (01)10757770637536(17)280131(11)250207(10)3R03226
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P240005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: EN
• Device Catalogue Number: ENU1200
• Device Lot Number: 3R03226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/11/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 08/06/2025
• Supplement Report FDA Received Date: 09/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AMVISC PLUS, ALCON MONARCH INJECTOR.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male